Eli Lilly has reported additional data suggesting that its Alzheimer’s drug solanezumab could still have a role to play in treatment, despite missing its targets in two phase III trials.
The pharma company says that data from a pooled analysis from the studies shows that solanezumab slowed cognitive decline in a subgroup of patients with mild Alzheimer’s disease by 34 per cent over 18 months, compared to 18 per cent with placebo, which was a significant difference.
The anti-amyloid antibody also slowed functional decline in the patients by 17 per cent, but this was not significantly better than placebo, according to the data, which was analysed by an independent team from the Alzheimer’s Disease Cooperative Study (ADCS) research consortium.
Lilly first reported the results of the trial involving mild and moderate Alzheimer’s patients in August, and said yesterday that the independent analysis was in line with its own findings and suggests there may be some value in continuing to develop solanezumab.
Analysts had all but written off the chances of Lilly getting positive results from its solanezumab trials after an intravenous formulation of similar anti-amyloid antibody – Pfizer and Johnson & Johnson’s bapineuzumab – showed no benefit in pivotal trials. A subcutaneous formulation of the Pfizer drug is however still in testing.
“While the path forward has not been determined, we believe these data in patients with mild disease may provide a step toward a potential treatment option,” said David Ricks, president of Lilly Bio-Medicines.
The next steps for solanezumab will be determined after discussions with regulators, he added, raising speculation that the company may be considering another study to confirm the secondary analysis data.
Solanezumab’s activity in a subgroup of patients with mild Alzheimer’s will lend credence to the view that anti-amyloid therapies must be delivered very early on in the course of the disease to have an impact.
Earlier this year, Genentech launched an ambitious study aiming to test that hypothesis in which its crenezumab antibody will be used to try to prevent Alzheimer’s in healthy patients at high risk of developing the disease.
Rachelle Doody, a member of the ADCS who presented the results at the annual meeting of the American Neurological Association (ANA), noted that “the data … from the solanezumab phase III trials were encouraging to the ADCS team”.
“These results represent an important step for the medical, academic, and scientific communities in understanding brain amyloid as a target of Alzheimer’s disease therapies,” she added.